Xochitl Halaby

Oct 3, 2024 | lexology.com | Jonathan Diesenhaus |Jessica Ellsworth |Michele Sartori |Emily Lyons |Xochitl Halaby |Mike Dohmann | +1 more

Since June 2023, the False Claims Act (FCA) bar has waited with baited breath for district courts to address Justice Thomas’s dissent in United States ex rel. Polansky v. Executive Health Resources, Inc., suggesting that the qui tam provisions of the federal civil False Claims Act – which allow a private citizen whistleblower or qui tam relator to file and pursue an FCA case even if the government declines to join or intervene in the suit – may be an unconstitutional delegation of power.

Sep 23, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Kathleen Peterson |Samantha Marshall |Mahmud Brifkani |Rianna Modi | +4 more

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.

Jul 29, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Stuart Langbein |Kathleen Peterson |Samantha Marshall |Mahmud Brifkani | +2 more

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers.

Apr 2, 2024 | jdsupra.com | Melissa Bianchi |Mahmud Brifkani |Xochitl Halaby

In light of the court’s ruling, the Oregon Department of Consumer and Business Services (DCBS) announced on February 21 that it is indefinitely suspending enforcement of the Act’s annual price increase reporting requirement, but that other manufacturer drug price reporting obligations, including the new drug and 60-day advance notice of price increase reporting requirements, are still in effect. The PhRMA v.

Apr 1, 2024 | lexology.com | Melissa Bianchi |James Huang |Mahmud Brifkani |Breanna Reeves |Xochitl Halaby |Rebecca Popkin

On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part PhRMA’s motion for summary judgment in its challenge to the Prescription Drug Price Transparency Act (the Act).